Transcatheter Aortic Valve Implantation in Patients Who Cannot Undergo Transfemoral Access.

INTRODUCTION: Though transfemoral (TF) access has emerged as a gold standard access for patients with aortic stenosis who undergo transcatheter aortic valve implantation (TAVI), there has been no study that has characterized patients who cannot undergo TF access in detail. We aim to evaluate the contraindications for TF access, their incidence, classify them, and provide the outcomes of patients who failed to be TF candidates. METHODS: From 925 patients who underwent TAVI between February 2014 and May 2020 at our heart center, 130 patients failed to be TF candidates and underwent transapical-transcatheter aortic valve implantation (TA-TAVI). In this study, we included all those patients who failed to be TF candidates and underwent TA-TAVI using the third-generation balloon expandable valve (Edwards SAPIEN 3 valve [S3]) (116 patients; STS score 6.07 ± 4.4; age 79.4 ± 7). RESULTS: The incidence of patients unsuitable for TF access at our heart center was 14%. We classified this TAVI population into absolute contraindication for TF access n = 84 (72.5%) and increased interventional risk for TF access n = 32 (27.5%). After TA-TAVI of this specific population using S3, the in-hospital mortality and stroke were 1.7 and 1.7%, respectively. The vascular injury rate was 1.7%. We registered no paravalvular leakage ≥2. The pacemaker rate was 7.4%. The mean transvalvular pressure gradient was 8.7 mm Hg. CONCLUSION: The incidence of patients who cannot undergo TF access or who are at high interventional risk is considerably high. TA-TAVI, supported with sufficient interventional experience and appropriate valve system, represents an excellent alternative for patients with distinct vasculopathy.

Oversized versus Non-oversized Prosthesis: Midterm Outcomes after Transcatheter Aortic Valve Replacement Using SAPIEN 3 Valve.

BACKGROUND: A certain degree of prosthesis oversizing is recommended for the SAPIEN 3 (S3; Edwards Lifesciences Corp., Irvine, California, United States) to ensure device success. We aimed to investigate midterm outcomes in patients who received oversized (OS) S3 valve after transapical-transcatheter aortic valve replacement (TA-TAVR). METHODS: Out of 122 patients with aortic stenosis who underwent TA-TAVR using S3 at our institution, 42 received OS prosthesis. We used computed tomography (CT) derived effective diameter to assess oversizing. We defined oversizing if the labeled diameter of the selected valve for implantation was ≥2 mm bigger than the effective annulus diameter calculated by the annulus area. We conducted a midterm follow-up and compared the OS cohort with the non-OS (nOS) cohort. RESULTS: The study groups showed similar risk score and age (STS [Society of Thoracic Surgery] score: 5.4 ± 3; mean age: 80.7 ± 5.7). The 30-day mortality was 7.1% in OS versus 2.4% in nOS. The 30-day all-stroke was 2.4% in OS versus 0% in nOS. The 1- and 3-year all-cause mortality were 28.5 and 42.8% in OS versus 21.9 and 26.8% in nOS, respectively. Midterm freedom from death and from cardiocerebral events was similar in both groups. Moderate/severe paravalvular leakage occurred in 0% in OS versus 5.4% in nOS. The postdilation rate was 7.1% in OS versus 15.3% in nOS. The rate of new permanent pacemaker implantation (PPI) was 15.7% in OS versus 9.3% in nOS. The STS score was detected as an independent predictor of mortality. CONCLUSION: Oversizing reduces the risk of device failure and intraprocedural postdilation but increases the risk of PPI. Early and midterm morbidity and mortality after OS and nOS with S3 are comparable.

Impact of diverse aortic pathologies on outcomes after transapical transcatheter aortic valve replacement.

OBJECTIVES: Some patients who undergo transcatheter aortic valve replacement (TAVR) have a concomitant diverse aortic pathologies (AP). They are usually considered high-risk candidates for the procedure and require further assessment to determine the best vascular approach. The impact of these AP on TAVR is not well known as the information is scarce. We aimed to evaluate midterm clinical impact of different AP after transapical (TA)-TAVR. METHODS: Twenty patients with atherosclerotic/occluding aortic diseases (A/OAD) (porcelain aorta, Leriche Syndrome, penetrating aortic ulcer, and aortic thrombus), 24 patients with aortic morphologic diseases (AMD) (thoracic/abdominal aortic aneurysms, aortic kinking, aortic type B dissection, aortic elongation/tortuosity, and previous aortic intervention), and 11 patients with combined aortic diseases (CAD) underwent TA-TAVR treatment between January 2011 and November 2019 at our center. We conducted up to 5-years clinical follow-up. RESULTS: All patients were classified in the heart team as a high interventional risk. The 30-day mortality and stroke were 5% and 10% in the A/OAD, 8.3% and 0% in the AMD, and 0% and 0% in the CAD, respectively. The median time of freedom from a composite of death and cardio-cerebral adverse events was 22.1 months [95% confidence interval [CI]: 9.9-34.3] in A/OAD versus 34.3 months [95% CI: 15.6-53] in AMD versus 17 months [95% CI: 0-39.4] in CAD; p = .525. We registered neither procedural aortic injury nor aortic syndrome at follow-up. The moderate/severe paravalvular leakage rates were 5%, 0% and 0% in the A/OAD, AMD and CAD, respectively. CONCLUSION: Independent of underlying AP, the TA-TAVR is a safe method and shows very promising early and midterm outcomes in patients with various AP.

Transcatheter aortic valve replacement using the SAPIEN 3 valve versus surgical aortic valve replacement using the rapid deployment INTUITY valve: Midterm outcomes.

OBJECTIVES: Little data have been published on the midterm effect of transapical/transfemoral-transcatheter aortic valve replacement (TA-/TF-TAVR) using the Edwards SAPIEN 3 valve (S3). We aimed to compare the outcomes after TA-/TF-TAVR utilizing the S3 (TA-/TF-S3) valve with those after surgical aortic valve replacement utilizing the rapid deployment Edwards INTUITY valve (RD-SAVR). METHODS: Between March 2012 and April 2018, 122 patients with aortic stenosis underwent TA-S3, 77 patients underwent TF-S3 and 182 patients underwent RD-SAVR through partial sternotomy at our institution. We conducted clinical and echocardiographic midterm follow-ups. The primary outcomes of the study were the incidence of new pacemakers permanent pacemaker implantation (PPI), the occurrence of paravalvular leakage (PVL) and the hemodynamic performance of the valves. RESULTS: All study groups were at intermediate surgical risk. The 30-day all-cause mortality and stroke rates in the TA-S3, TF-S3, and RD-SAVR groups were 4.1% and 1.6%, 3.9% and 2.6%, and 3.8% and 2.2%, respectively. The RD-SAVR group had significantly smaller PVL and PPI rates than did the TA-/TF-S3 group (p < .0001). At the discharge, the one-year postprocedure mean gradients were 9 ± 5.1/10 ± 4.5 mmHg, 11 ± 4.1/12 ± 3.8 mmHg, and 10.1 ± 4.3/10.4 ± 2.6 mmHg in the TA-S3, TF-S3, and RD-SAVR groups, respectively. Midterm valve thrombosis, Re-TAVR/SVAR were low and similar among the study groups, whereas endocarditis was higher in the TAVR group. CONCLUSION: RD-SAVR was superior to TA-/TF-S3 in the PVL and PPI rates. We observed similar early outcomes and valve hemodynamics. The endocarditis was higher in the TAVR group.

Transapical-transcatheter aortic valve implantation using the Edwards SAPIEN 3 valve.

BACKGROUND: Scarcely any data has been published on the mid-term effect of transapical-transcatheter aortic valve implantation (TA-TAVI) using the Edwards SAPIEN 3 valve (S3; Edwards Lifesciences Corp., Irvine, CA, USA). We present mid-term clinical and echocardiographic outcomes after TA-TAVI utilizing S3. METHODS: Between 02/2014-06/2017, 122 elderly patients with severe aortic stenosis underwent TA-TAVI utilizing S3 at our institution. We conducted clinical and echocardiographic follow-up. The mean follow-up was 15 months. All end-point-related outcomes were adjudicated according to Valve Academic Research Consortium-2 definitions. RESULTS: The STS-score of the entire cohort was 6.26±4.6. More than one-third of the patients exhibited severe peripheral artery disease. The 30-d all-cause mortality, all-stroke rate, and myocardial infarction of the entire cohort were 4.1%, 1.6%, and 0.8% respectively. Median survival time of the entire cohort was 35 months. The cumulative mid-term myocardial infarction and stroke rate was 2.6% and 3.5%, respectively. The postoperative moderate/severe paravalvular leakage occurred in 1.6% of cases. At discharge, one-year and two-year postprocedure peak/mean gradients were 16.6±8.3/ 9±5.1 mmHg, 18±6.9/ 10±4.5 mmHg, and 22.2±5.4/ 12.8±4.6 mmHg, respectively. The rate of new pacemaker cases was 14.1%. Acute kidney injury network 2/3 appears, as an independent predictor of mortality. CONCLUSIONS: We observed very promising early and mid-term clinical outcomes with a high degree of device success and good hemodynamic performance after TA-TAVI using the S3 in the intermediate risk patient profile.

Transapical transcatheter aortic valve implantation in patients with aortic diseases.

OBJECTIVES: Patients scheduled for transcatheter aortic valve implantation (TAVI) treatment frequently present with concomitant aortic diseases, in which case they are usually considered to be at high interventional risk and, in particular, unable to undergo the transfemoral TAVI approach. Since the establishment of the 'transfemoral first' strategy for TAVI, there has been an evidence gap with regard to the outcomes of such patients. We aimed to evaluate the mid-term outcomes after transapical TAVI in patients with diverse aortic diseases. METHODS: Fifty-five consecutive elderly patients (78.4 years; standard deviation: 8.6 years) at intermediate surgical risk with severe aortic stenosis and aortic diseases (porcelain aorta 36%, ascending aneurysm 15%, descending aneurysm 26%, type-B dissection 4%, aortic thrombus 7%, Leriche syndrome 4%, aortic kinking 11%, aortic ulcer 2%, previous aortic operation 20%, aortic elongation/tortuosity 4%) underwent transapical TAVI treatment between January 2011 and November 2019 at our institution. We used the second-and third-generation self- and balloon-expanding valves. The follow-up time was 92.6 patient-years. RESULTS: The Society of Thoracic Surgery-Predicted Risk of Mortality score was 7% (standard deviation: 4%). The 30-day mortality and all-stroke rates were 6% and 4%, respectively. The median survival time was 24.9 months (95% confidence interval 17.6-32.3). The median time of freedom from a composite of death and cardio-cerebral adverse events was 24.3 months (95% confidence interval 11.9-36.8). The rate of moderate/severe paravalvular leakage was 2%. The pacemaker rate was 10%. No early or late aortic syndrome occurred. CONCLUSIONS: Transapical TAVI is a safe method and shows very promising early and mid-term outcomes, without early/late aortic syndrome, in patients with aortic diseases for whom transfemoral TAVI as the first-line transcatheter method might be contraindicated or not feasible.

Valve-in-Valve After Edwards INTUITY Valve Implantation in Small Aortic Annulus.

The Edwards INTUITY aortic valve has in recent years played a significant role in facilitating surgical aortic valve replacement. Owing to the excellent hemodynamic characteristics and relatively new usage of this bioprosthetic aortic valve, the structural valve deterioration is an extremely rare complication; therefore, the treatment options of degenerated INTUITY valve with stenotic features have not been studied. We report the feasibility and safety of transcatheter valve-in-valve treatment for degenerated, stenotic INTUITY valve using the balloon expanding transcatheter aortic valve SAPIEN 3 in a small aortic annulus.